brazilian and italian evaluation of safety using tacrolimus-eluting stent with short-term dual antiplatelet regimen

Conditions: Stable Coronary Disease; Unstable Coronary Disease; Documented Silent Ischemia

Summary: to evaluate the safety and efficacy of the janus optima tacrolimus-eluting stent (optima tes, cid) for the treatment of de novo coronary lesions when associated with short-term (two months) dual antiplatelet (aspirin + clopidogrel) regimen.

the present study is a post-market, prospective, international, two-center, single arm study involving 60 patients with single, de novo non-complex coronary lesions. enrolled patients will be asked to return for follow-up clinical evaluation at 1, 6, 12 and 24 months. at 3 months there will be an additional follow-up by phone contact. furthermore, the first 15 patients should undergo angiographic and oct follow-up at two months. the remaining 45 patients should undergo angiographic and ivus follow-up at 8 months.

Eligibility criteria:
inclusion criteria: * patient with \>18 years of age; * symptoms of stable or unstable angina and/or presence of a positive functional test for ischemia; * presence of a single de novo target lesion located in a native coronary vessel suitable for percutaneous treatment with the study stents; * acceptable candidate for coronary artery bypass graft(cabg)surgery; * the subject is willing to sign a written informed consent prior to procedure, and is willing to undergo all study protocol follow-ups,including angiographic, ivus and oct assessments. * single, de novo lesion * target lesion located in a major epicardial coronary vessel with reference of 2.5-3.5mm in diameter (by on-line qca) * target lesions ≤19mm in length (by visual estimation) that can be treated (covered) by one single study stent (19 or 24mm in length); * ≥50% and \<100% diameter stenosis; * timi (thrombolysis in myocardial infarction) flow grade ≥2. exclusion criteria: * known hypersensitivity or contraindication to tacrolimus, heparin,any required medications including thienopyridines, and contrast media which cannot be adequately pre medicated; * patient is a female with childbearing potential; * pre-treatment of the target lesion with any devices other than balloon angioplasty; * previous brachytherapy in the target vessel; * presence of non-target vessel lesions which require staged procedure(s) \<30 days of the index procedure; * prior cabg surgery to target vessel; * previous percutaneous coronary intervention (pci) or cabg surgery \<30 days to the index procedure date; * acute myocardial infarction \ 2 times the upper normal limit value and/or ck-mb above the upper normal limit value within the past 72 hours; * ck and/or ck-mb levels elevated above the upper normal limit value at the time of the index procedure; * documented left ventricular ejection fraction \<30%; * renal insufficiency determined by a baseline serum creatinine \>2.0 mg/dl; * thrombocytopenia with a baseline platelet count \<100,000 cells/mm3; * anemia with baseline hemoglobin \<10g/dl; * extensive peripheral vascular disease or extreme anticoagulation that precludes safe \>5 french sheath insertion; * history of bleeding diathesis, coagulopathy, or refusal of blood transfusions; * patients has suffered a stroke, transient ischemic attack (tia),or cerebrovascular accident (cva) within the past 6 months; * significant gastrointestinal or genitourinary bleed within the past 6 months; * patient is a recipient of a heart transplant; * any elective surgical procedure is planned within 12 months of the index procedure; * known illness or any serious clinical condition with life expectancy \<2 years; * participation in the active or follow-up phase of any other clinicaltrial within 6 months; * impossibility to comply with anti-platelet therapy during the study clinical follow-up; * any impossibility to comply with all protocol follow-ups. * target lesion or vessel with angiographic evidence of moderate or severe calcification; * presence of severe tortuosity; * presence of severe angulation (\>60o); * presence of intraluminal thrombus; * target lesion involving a bifurcation (side branch ≥2.0mm); * target lesion located in the left main stem; * aorto-ostial lesion location; * target lesion involving a side branch with reference diameter≥2.0mm; * presence of a significant stenosis (\>40%) in the target vessel either proximal or distal to the target lesion that will be untreated; * previous placement of a stent within 10mm of the target lesion; * total occlusion (timi flow grade 0 or 1); * target lesion located in an arterial or vein graft; * target lesion due to in-stent restenosis; * coronary anatomy unsuitable for percutaneous treatment with implantation of the available study stents.

Keywords: optima tacrolimus drug eluting stent